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ID

44091

Description

Study ID: 107979 Clinical Study ID: TXA107979 Study Title: TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00843024 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: sumatriptan/naproxen Trade Name: Treximet Study Indication: Migraine Disorders CRF Seiten: 879-993

Keywords

Versions (3)
  1. 6/21/18 6/21/18 -
  2. 6/21/18 6/21/18 -
  3. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY-NC 3.0
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    TXA107979: Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine NCT00843024

    English

    Attack 1 Diary

    1 forms  
    1. StudyEvent: ODM
      1. Attack 1 Diary
    Date of Visit/Assessment
    Description

    Date of Visit/Assessment

    Alias
    UMLS CUI-1
    C1320303 (Date of visit)
    SNOMED
    406543005
    Date of Visit/Assessment
    Description

    Date of Visit

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303 (Date of visit)
    SNOMED
    406543005
    Migraine attack 1 symptoms
    Description

    Migraine attack 1 symptoms

    Alias
    UMLS CUI-1
    C0149931 (Migraine Disorders)
    UMLS CUI-2
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    Enter the date and time your migraine headache pain started
    Description

    start date migraine attack

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Did you wake up with your migraine headache pain?
    Description

    woke up with migraine headache pain

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0442696 (Waking)
    SNOMED
    255377004
    UMLS CUI [1,2]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,3]
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    Did you have aura?
    Description

    migraine with aura

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0154723 (Migraine with Aura)
    SNOMED
    4473006
    Pain worsened by physical activity?
    Description

    pain worsened by physical activity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    UMLS CUI [1,2]
    C4054844 (Have Pain Increase with Activity)
    What best describes the quality of your migraine headache pain?
    Description

    migraine headache pain quality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,2]
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    UMLS CUI [1,3]
    C1148406 (Pain quality)
    LOINC
    LP34364-7
    What best describes the location of your migraine headache pain?
    Description

    migraine headache pain location

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,2]
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    UMLS CUI [1,3]
    C0030193 (Pain)
    SNOMED
    22253000
    LOINC
    MTHU029813
    UMLS CUI [1,4]
    C0450429 (Location)
    SNOMED
    246267002
    LOINC
    LP149876-7
    Investigational Product
    Description

    Investigational Product

    Start date
    Description

    Start date

    Data type

    date

    Measurement units
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0808070 (Start Date)
    DDMONYYYY
    Start time
    Description

    Start time

    Data type

    time

    Measurement units
    • hh:mm
    Alias
    UMLS CUI [1]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    hh:mm
    Stop Date
    Description

    Stop Date

    Data type

    date

    Measurement units
    • DDMONYYYY
    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    DDMONYYYY
    Migraine attack 1 headache pain and symptoms
    Description

    Migraine attack 1 headache pain and symptoms

    Alias
    UMLS CUI-1
    C0149931 (Migraine Disorders)
    UMLS CUI-2
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    UMLS CUI-3
    C0030193 (Pain)
    SNOMED
    22253000
    LOINC
    MTHU029813
    UMLS CUI-4
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    Time since drug intake
    Description

    time since drug intake

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    UMLS CUI [1,3]
    C1512806 (Intake)
    How severe is your migraine headache pain?
    Description

    migraine headache pain with scale

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0149931 (Migraine Disorders)
    UMLS CUI [1,2]
    C0018681 (Headache)
    SNOMED
    25064002
    LOINC
    MTHU020860
    UMLS CUI [1,3]
    C1504479 (Pain scale)
    LOINC
    MTHU051379
    Nausea symptoms
    Description

    Nausea

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0027497 (Nausea)
    SNOMED
    422587007
    LOINC
    LP36327-2
    Vomiting symptom
    Description

    Vomiting

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0042963 (Vomiting)
    SNOMED
    422400008
    LOINC
    MTHU013530
    Light sensitivity symptom
    Description

    Light sensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085636 (Photophobia)
    SNOMED
    246622003
    LOINC
    LA24849-4
    Sound sensitivity symptom
    Description

    Sound sensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2938899 (Sound sensitivity increased)
    Medications taken
    Description

    Medications taken

    Alias
    UMLS CUI-1
    C2347852 (Concomitant Agent)
    Sequence Number
    Description

    Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348184 (Sequence Number)
    Drug name (Trade name preferred)
    Description

    Drug name

    Data type

    text

    Alias
    UMLS CUI [1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    Modified reported term
    Description

    Modified reported term

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826819 (Concomitant Medication Modified Reported Term)
    Date and time medication taken
    Description

    Date and time medication taken

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Primary Reason Medication Taken
    Description

    Primary Reason Medication Taken

    Data type

    text

    Specify other reason
    Description

    Specify other reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696 (Concomitant Medication Use Indication)
    Ability to function
    Description

    Ability to function

    Alias
    UMLS CUI-1
    C0441655 (Activities)
    SNOMED
    257733005
    LOINC
    LA28168-5
    UMLS CUI-2
    C0085732 (Ability)
    Time since drug intake
    Description

    time since drug intake

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0011008 (Date in time)
    SNOMED
    410671006
    UMLS CUI [1,2]
    C0304229 (Experimental drug)
    UMLS CUI [1,3]
    C1512806 (Intake)
    How do you rate your ability to do school work or perform you usual activities?
    Description

    ability to perform usual activities

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0441655 (Activities)
    SNOMED
    257733005
    LOINC
    LA28168-5
    UMLS CUI [1,2]
    C0085732 (Ability)
    Investigational product accountability
    Description

    Investigational product accountability

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0078889 (Accountability)
    Investigational product container numbers assigned
    Description

    investigational product container number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C3898691 (Investigational Medicinal Product Documentation)
    UMLS CUI [1,2]
    C0449788 (Count of entities)
    SNOMED
    410681005
    Total Number of Tablets Dispensed
    Description

    total number of tablets dispensed

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0805077 (Dispensed Amount)
    UMLS CUI [1,2]
    C0039225 (Tablet Dosage Form)
    SNOMED
    385055001
    LOINC
    LP136501-6
    Total Number of Tablets taken
    Description

    total number of tablets taken

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0039225 (Tablet Dosage Form)
    SNOMED
    385055001
    LOINC
    LP136501-6
    UMLS CUI [1,2]
    C0237753 (Numbers)
    SNOMED
    260299005
    LOINC
    LP6841-3
    UMLS CUI [1,3]
    C1883727 (Taken)
    Returned Date
    Description

    Returned Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C0180098 (Containers)
    SNOMED
    706437002
    UMLS CUI [1,3]
    C0332156 (Return to (contextual qualifier) (qualifier value))
    SNOMED
    7528007
    UMLS CUI [1,4]
    C0011008 (Date in time)
    SNOMED
    410671006
    Sequence Number
    Description

    Sequence Number

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1519255 (Serious Adverse Event)
    UMLS CUI [1,2]
    C2348184 (Sequence Number)
    Total Number of Tablets Returned
    Description

    total number of tablets returned

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C2699071 (Returned Amount)
    UMLS CUI [1,2]
    C0039225 (Tablet Dosage Form)
    SNOMED
    385055001
    LOINC
    LP136501-6
    Investigational Product
    Description

    Investigational Product

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    Date and time of second tablet
    Description

    Date and time of second tablet

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0013227 (Pharmaceutical Preparations)
    SNOMED
    763158003
    LOINC
    LP100609-9
    UMLS CUI [1,2]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Language used in diary assessment
    Description

    Language used in diary assessment

    Alias
    UMLS CUI-1
    C3890583 (Subject Diary)
    UMLS CUI-2
    C0023008 (Languages)
    SNOMED
    61909002
    ISO language
    Description

    ISO language

    Data type

    text

    Alias
    UMLS CUI [1]
    C1708640 (Language Code)
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    Similar models

    Attack 1 Diary

    1 forms
    1. StudyEvent: ODM
      1. Attack 1 Diary
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Date of Visit/Assessment
    C1320303 (UMLS CUI-1)
    Date of Visit
    Item
    Date of Visit/Assessment
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Migraine attack 1 symptoms
    C0149931 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    start date migraine attack
    Item
    Enter the date and time your migraine headache pain started
    datetime
    C0149931 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    woke up with migraine headache pain
    Item
    Did you wake up with your migraine headache pain?
    boolean
    C0442696 (UMLS CUI [1,1])
    C0149931 (UMLS CUI [1,2])
    C0018681 (UMLS CUI [1,3])
    migraine with aura
    Item
    Did you have aura?
    boolean
    C0154723 (UMLS CUI [1])
    pain worsened by physical activity
    Item
    Pain worsened by physical activity?
    boolean
    C0018681 (UMLS CUI [1,1])
    C4054844 (UMLS CUI [1,2])
    Item
    What best describes the quality of your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1148406 (UMLS CUI [1,3])
    migraine headache pain quality
    Code List
    What best describes the quality of your migraine headache pain?
    CL Item
    Pulsing, throbbing, or pounding pain (1)
    CL Item
    Pressure/tightening (2)
    Item
    What best describes the location of your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C0030193 (UMLS CUI [1,3])
    C0450429 (UMLS CUI [1,4])
    migraine headache pain quality
    Code List
    What best describes the location of your migraine headache pain?
    CL Item
    Only one side of head (1)
    CL Item
    On both sides of head (2)
    Item Group
    Investigational Product
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1])
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Migraine attack 1 headache pain and symptoms
    C0149931 (UMLS CUI-1)
    C0018681 (UMLS CUI-2)
    C0030193 (UMLS CUI-3)
    C1457887 (UMLS CUI-4)
    Item
    Time since drug intake
    text
    C0011008 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1512806 (UMLS CUI [1,3])
    time since drug intake
    Code List
    Time since drug intake
    CL Item
    0 hour (at time of dosing) (1)
    (Comment:en)
    CL Item
    1 hour after dose (2)
    (Comment:en)
    CL Item
    2 hous after dose (3)
    (Comment:en)
    CL Item
    4 hours after dose (4)
    (Comment:en)
    Item
    How severe is your migraine headache pain?
    text
    C0149931 (UMLS CUI [1,1])
    C0018681 (UMLS CUI [1,2])
    C1504479 (UMLS CUI [1,3])
    migraine headache pain with scale
    Code List
    How severe is your migraine headache pain?
    CL Item
    None (1)
    CL Item
    Mild (2)
    CL Item
    Moderate (3)
    CL Item
    Severe (4)
    Nausea
    Item
    Nausea symptoms
    boolean
    C0027497 (UMLS CUI [1])
    Vomiting
    Item
    Vomiting symptom
    integer
    C0042963 (UMLS CUI [1])
    Light sensitivity
    Item
    Light sensitivity symptom
    boolean
    C0085636 (UMLS CUI [1])
    Sound sensitivity
    Item
    Sound sensitivity symptom
    boolean
    C2938899 (UMLS CUI [1])
    Item Group
    Medications taken
    C2347852 (UMLS CUI-1)
    Sequence Number
    Item
    Sequence Number
    text
    C2348184 (UMLS CUI [1])
    Drug name
    Item
    Drug name (Trade name preferred)
    text
    C0013227 (UMLS CUI [1])
    Modified reported term
    Item
    Modified reported term
    text
    C2826819 (UMLS CUI [1])
    Date and time medication taken
    Item
    Date and time medication taken
    datetime
    C0013227 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    Primary Reason Medication Taken
    text
    Primary Reason Medication Taken
    Code List
    Primary Reason Medication Taken
    CL Item
    Mild Migraine Headache Pain (1)
    CL Item
    Moderate Migraine Headache Pain (2)
    CL Item
    Severe Migraine Headache Pain (3)
    CL Item
    Other Reason, Specify (4)
    Specify other reason
    Item
    Specify other reason
    text
    C2826696 (UMLS CUI [1])
    Item Group
    Ability to function
    C0441655 (UMLS CUI-1)
    C0085732 (UMLS CUI-2)
    Item
    Time since drug intake
    text
    C0011008 (UMLS CUI [1,1])
    C0304229 (UMLS CUI [1,2])
    C1512806 (UMLS CUI [1,3])
    time since drug intake
    Code List
    Time since drug intake
    CL Item
    0 hour (at time of dosing) (1)
    (Comment:en)
    CL Item
    1 hour after dose (2)
    (Comment:en)
    CL Item
    2 hous after dose (3)
    (Comment:en)
    CL Item
    4 hours after dose (4)
    (Comment:en)
    Item
    How do you rate your ability to do school work or perform you usual activities?
    text
    C0441655 (UMLS CUI [1,1])
    C0085732 (UMLS CUI [1,2])
    ability to perform usual activities
    Code List
    How do you rate your ability to do school work or perform you usual activities?
    CL Item
    Normal (1)
    CL Item
    Mildly impaired (2)
    CL Item
    Moderately impaired (3)
    CL Item
    Severely impaired (4)
    CL Item
    Required bedrest (5)
    Item Group
    Investigational product accountability
    C0304229 (UMLS CUI-1)
    C0078889 (UMLS CUI-2)
    investigational product container number
    Item
    Investigational product container numbers assigned
    integer
    C3898691 (UMLS CUI [1,1])
    C0449788 (UMLS CUI [1,2])
    total number of tablets dispensed
    Item
    Total Number of Tablets Dispensed
    integer
    C0805077 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    total number of tablets taken
    Item
    Total Number of Tablets taken
    integer
    C0039225 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    C1883727 (UMLS CUI [1,3])
    Returned Date
    Item
    Returned Date
    date
    C0013227 (UMLS CUI [1,1])
    C0180098 (UMLS CUI [1,2])
    C0332156 (UMLS CUI [1,3])
    C0011008 (UMLS CUI [1,4])
    Sequence Number
    Item
    Sequence Number
    text
    C1519255 (UMLS CUI [1,1])
    C2348184 (UMLS CUI [1,2])
    total number of tablets returned
    Item
    Total Number of Tablets Returned
    integer
    C2699071 (UMLS CUI [1,1])
    C0039225 (UMLS CUI [1,2])
    Item Group
    Investigational Product
    C0304229 (UMLS CUI-1)
    Date and time of second tablet
    Item
    Date and time of second tablet
    datetime
    C0013227 (UMLS CUI [1,1])
    C1264639 (UMLS CUI [1,2])
    Stop Date
    Item
    Stop Date
    date
    C0806020 (UMLS CUI [1])
    Item Group
    Language used in diary assessment
    C3890583 (UMLS CUI-1)
    C0023008 (UMLS CUI-2)
    ISO language
    Item
    ISO language
    text
    C1708640 (UMLS CUI [1])
    Back to the top of the page 

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